Transdermal Fluid Removal in Fluid Overload

NHS Foundation Trust

Status: Completed

Conditions: Odema; Heart Failure

Treatments: Device: Transdermal Fluid Removal

Study type: Interventional

Funder types: Other

Identifiers

NCT03959930

B00097

Details and patient eligibility

About

The proposed study seeks to explore the possibility of significantly increasing the success rate (from the current rate of 28%) of clinically significant Transdermal Fluid Removal (TFR) in heart failure patients. It seeks to further understand the device and patient characteristics influencing successful clinically relevant fluid removal and to measure any patient-defined benefits. It also wishes to explore the patient experience of the removal.

Full description

Fluid overload is distressing and is particularly prevalent in patients with vital organ dysfunction such as in kidney and heart disease. Due to the patient's inability to remove excess wastes and water, these accumulate in their body fluid compartments. Such excess fluid and toxins have to be removed with high dose diuretics (water tablets or injections) or by frequent dialysis. Treatment with diuretics is effective initially in some patients but is fraught with risks and side effects. The retained fluid and wastes are mainly lodged within the extracellular compartment (interstitial or tissue fluid) and exert deleterious effects on cell functions. Much of this excess fluid collects relatively superficially within the skin, especially in the lower extremities or other dependent body parts as oedema.

The proposed study seeks to explore the possibility of significantly increasing the success rate (from the current rate of 28%) of clinically significant Transdermal Fluid Removal (TFR) in heart failure patients. It seeks to further understand the device and patient characteristics influencing successful clinically relevant fluid removal and to measure any patient-defined benefits. It also wishes to explore the patient experience of the removal.

Principal aim of the research: To investigate whether the TFR device can remove clinically viable or relevant volumes of fluid transdermally in advanced heart failure and other patients with significant oedema. "Clinically viable" volume is defined as the removal of 200ml or more of fluid in a session of up to 10 hours (or 0.43 ml/h per 1cm2 of the skin area treated with microneedles).

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants aged >18 years
• Diagnosis of heart failure
• Presence of visible oedema

Exclusion criteria

• Inability to give consent
• Patient on warfarin or simthrome (acecoumarol) with International Normalised Ratio (INR) >3 or other bleeding disorders
• Extensive skin disease, infected or broken skin over intended study area
• Pregnancy NB: Patients with pacemakers or implantable cardiac devices (ICD) may be recruited but will not have bioimpedance measurements

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Interventional arm

Experimental group

Description:

Total and segmental body fluid volumes (total water, extracellular water and interstitial water) will be measured by Segmental Bioelectrical Impedance Spectroscopy (as per manufacturer instructions of use). Areas with most significant oedema and skin in a suitable condition shall be selected for the TFR application. Moisture Meter shall be used at the selected site to measure the skin water content at 4 depths (0.5mm, 1.5mm, 2.5mm and 5mm).

Treatment:

Device: Transdermal Fluid Removal